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An Exploratory Investigation of a Supplement to Support Student Learning

Primary Purpose

Concentration Ability Impaired, Mental Fatigue

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GeniusDrops
Sponsored by
JoySpring
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Concentration Ability Impaired

Eligibility Criteria

5 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Provision of signed and dated informed consent form and a parental assent form
  • Must be experiencing issues with focus, mood, and memory
  • Must be looking to improve classroom performance
  • Gets easily distracted

Exclusion Criteria:

  • Diagnosis of ADD or ADHD
  • Currently taking a prescription medication meant to treat ADD or ADHD
  • Diagnosed with additional conditions that would not allow them to adhere to the protocol.
  • Willing to take a supplement targeting improving mood, concentration, and focus

Sites / Locations

  • Citruslabs

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GeniusDrops

Arm Description

Once participants have signed the consent and assent, they will take the baseline survey to gather information about their ability to focus and concentration. Once in the study, participants will be asked to take two dropperfuls of the test product (Genius Drops) twice daily. The participants can take the dropperful directly or add it to drinks/snacks. Participants will need to be in school during the entirety of the study. Participants will take a subsequent survey after two weeks in the trial and then another survey at the end of the trial.

Outcomes

Primary Outcome Measures

Examination of self-reported focus
Participants will respond to a survey to assess perceived changes in focus.
Examination of Self-reported concentration
Participants will respond to a survey to assess perceived changes in concentration
Examination of Self-reported mood states
Participants will respond to a survey to assess perceived changes in moods.

Secondary Outcome Measures

Full Information

First Posted
September 1, 2022
Last Updated
September 1, 2022
Sponsor
JoySpring
Collaborators
Citruslabs
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1. Study Identification

Unique Protocol Identification Number
NCT05528094
Brief Title
An Exploratory Investigation of a Supplement to Support Student Learning
Official Title
An Exploratory Investigation of a Supplement to Support Student Learning
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 14, 2022 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JoySpring
Collaborators
Citruslabs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In this trial, the herbal supplement (GeniusDrops) will be tested to see the effects it has on the dependent variables of interest. Participants will take the supplement twice a day for a month and respond to surveys at study baseline, midpoint, and the conclusion of the study. The findings of this study will be used for marketing materials and to inform future trials using the supplement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concentration Ability Impaired, Mental Fatigue

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GeniusDrops
Arm Type
Experimental
Arm Description
Once participants have signed the consent and assent, they will take the baseline survey to gather information about their ability to focus and concentration. Once in the study, participants will be asked to take two dropperfuls of the test product (Genius Drops) twice daily. The participants can take the dropperful directly or add it to drinks/snacks. Participants will need to be in school during the entirety of the study. Participants will take a subsequent survey after two weeks in the trial and then another survey at the end of the trial.
Intervention Type
Dietary Supplement
Intervention Name(s)
GeniusDrops
Intervention Description
The active ingredients listed below are safe and the study sponsor has noted there are no known side effects of the supplement. The main ingredients are: Hibiscus flower- Has been shown to boost oxygenation to the brain and vital organs. Has also demonstrated efficacy for boosting the immune system. Gingko leaf- Has been shown to stimulate memory by increasing mental sharpness and clarity. Rhodiola- Helps regulate energy and stress level. Gotu kola- Has been shown to have impacts on reducing anxiety. Licorice Root- Helps boost the key brain neurotransmitter called Brain Derived Neurotrophic factor which can help with cognitive development Peppermint Leaf- Reduces fatigue while helping improve cognitive abilities. Has also been shown to promote immune system function.
Primary Outcome Measure Information:
Title
Examination of self-reported focus
Description
Participants will respond to a survey to assess perceived changes in focus.
Time Frame
4 weeks
Title
Examination of Self-reported concentration
Description
Participants will respond to a survey to assess perceived changes in concentration
Time Frame
4 weeks
Title
Examination of Self-reported mood states
Description
Participants will respond to a survey to assess perceived changes in moods.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated informed consent form and a parental assent form Must be experiencing issues with focus, mood, and memory Must be looking to improve classroom performance Gets easily distracted Exclusion Criteria: Diagnosis of ADD or ADHD Currently taking a prescription medication meant to treat ADD or ADHD Diagnosed with additional conditions that would not allow them to adhere to the protocol. Willing to take a supplement targeting improving mood, concentration, and focus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Hill
Organizational Affiliation
Citruslabs
Official's Role
Principal Investigator
Facility Information:
Facility Name
Citruslabs
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

An Exploratory Investigation of a Supplement to Support Student Learning

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